6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US N/A 610119

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for 6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US N/A 610119 manufactured by Terumo Medical Corporation.

Event Text Entries

[188888800] Expiration date - unknown due to unknown lot number. Udi - unknown due to unknown lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date - unknown due to unknown lot number. The actual device was not returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.
Patient Sequence No: 1, Text Type: N, H10


[188888801] The user facility reported that the transition on the angio-seal device sheath to the arteriotomy locator is so big and bulky they cannot get it into the vessel. They aborted use and held manual pressure. There was no negative patient outcome or additional bleeding. Additional information was received on 11mar2020. The procedure outcome was successful, there was no harm to the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3013394970-2020-00201
MDR Report Key9907717
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-05
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTHERESA MUSSAW
Manufacturer Street950 ELKTON BLVD.
Manufacturer CityELKTON, MD
Manufacturer CountryUS
Manufacturer Phone2837866718
Manufacturer G1TERUMO PUERTO RICO LLC
Manufacturer StreetINNOVACION STREET LOT 21 CAGUAS WEST INDUSTRIAL PARK
Manufacturer CityCAGUAS, 00725
Manufacturer Country*
Manufacturer Postal Code00725
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name6FR ANGIO-SEAL STS PLUS VASCULAR CLOSURE DEVICE, US
Generic NameDEVICE, HEMOSTASIS, VASCULAR
Product CodeMGB
Date Received2020-03-31
Model NumberN/A
Catalog Number610119
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO MEDICAL CORPORATION
Manufacturer Address265 DAVIDSON AVE SUITE 320 SOMERSET, NJ US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-31

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